Published Technical Documents
Standards, guidance and application literature from the bodies and manufacturers that publish it. Every entry links to the document page itself and quotes the sentence that says what it covers.
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U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K222148. Device: HemoScreen Hematology Analyzer. Applicant as listed: Pixcell Medical Technologies, Ltd.. Decision date: 2023-08-16.
Fuente: api.fda.gov · Consultado el 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K223867. Device: IDS ACTH II. Applicant as listed: Immunodiagnostic Systems Limited. Decision date: 2023-08-18.
Fuente: api.fda.gov · Consultado el 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K223590. Device: Access Folate Assay. Applicant as listed: Beckman Coulter, Inc.. Decision date: 2023-08-23.
Fuente: api.fda.gov · Consultado el 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K231517. Device: VITROS Immunodiagnostic Products CEA Reagent Pack. Applicant as listed: Ortho Clinical Diagnostics. Decision date: 2023-08-23.
Fuente: api.fda.gov · Consultado el 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K232215. Device: Quantra Hemostasis Analyzer. Applicant as listed: Hemosonics, LLC. Decision date: 2023-08-24.
Fuente: api.fda.gov · Consultado el 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K220085. Device: KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit. Applicant as listed: Kronus, Inc.. Decision date: 2023-08-24.
Fuente: api.fda.gov · Consultado el 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K213670. Device: BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection Tubes. Applicant as listed: Becton, Dickinson and Company. Decision date: 2023-08-25.
Fuente: api.fda.gov · Consultado el 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K231994. Device: Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Sulbactam-durlobactam in the dilution range of 0.015/4-32/4 ug/mL. Applicant as listed: Thermo Fisher Scientific. Decision date: 2023-08-25.
Fuente: api.fda.gov · Consultado el 2026-10-27
FDA 510(k) index record K231988. Device: Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dalbavancin in the dilution range of 0.0005-2µg/ml. Applicant as listed: Thermo Fisher Scientific. Decision date: 2023-08-30.
Fuente: api.fda.gov · Consultado el 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K231616. Device: ZEUS IFA(TM) nDNA Test System, ZEUS dIFine. Applicant as listed: Zeus Scientific. Decision date: 2023-08-31.
Fuente: api.fda.gov · Consultado el 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K231433. Device: The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL. Applicant as listed: Thermo Fisher Scientific. Decision date: 2023-08-31.
Fuente: api.fda.gov · Consultado el 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K222563. Device: BD Kiestra IdentifA. Applicant as listed: Becton, Dickinson and Company. Decision date: 2023-08-31.
Fuente: api.fda.gov · Consultado el 2026-10-27
Key takeaways
Every item here is a technical document its publisher made public: a standards-body scope page, a regulator guidance document, or a manufacturer application note or journal article. The entry links to that page and quotes the sentence describing what the document covers. It is not a record of work IVDmap has done.
Target audienceImplementation teams, labs, procurement managers
Review and references
Compiled from public manufacturer materials and regulatory sources. Not independently verified and not reviewed by a named clinician.
2026-10-01
2026-10-09
professional use
Every document below is published by the body named on it, and this page links to that page. Nothing here is a record of work IVDmap has done.